FDA.reportPublic FDA data

Application 125545

Type
BLA
Sponsor
HOSPIRA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125545Retacritepoetin alfa-epbx351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION2,000UNITS/MLNoNo
002RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION3,000UNITS/MLNoNo
003RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION4,000UNITS/MLNoNo
004RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION10,000UNITS/MLNoNo
005RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION40,000UNITS/MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RETACRITEPOETIN ALFA-EPBXVifor (International) Inc.e6e4dd0c-25ca-40b2-ba6b-6138a68621fe2025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545
ndc (product): 59353-002
ndc (product): 59353-003
ndc (product): 59353-004
ndc (product): 59353-010
RETACRITEPOETIN ALFA-EPBXPfizer Laboratories Div Pfizer Inc3af26b0d-8ad0-44e1-a538-8bdb5ab393742025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545
ndc (product): 0069-1308
ndc (product): 0069-1307
ndc (product): 0069-1306
ndc (product): 0069-1305
ndc (product): 0069-1318
ndc (product): 0069-1309
ndc (product): 0069-1311

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78649SUPPL 2024-06-05
78648SUPPL 2024-06-05
78635SUPPL 2024-06-05
74025SUPPL 2023-04-20
74024SUPPL 2023-04-19
63771SUPPL2020-07-01
63765SUPPL2020-07-01
63764SUPPL2020-07-01
57298SUPPL2019-01-22
57288SUPPL2019-01-22
57287SUPPL2019-01-22
56726ORIG2018-12-13
54190ORIG2018-05-15
54187ORIG2018-05-15
54186ORIG2018-05-15